March 07, 2018

"Off-label" Cases Aren't Going Away – DOJ Sheds Light on Direction of Enforcement of Misbranding Rules Governing Medical Products

5 min

On February 28, Ethan Davis, the U.S. Department of Justice's (DOJ) deputy assistant attorney general responsible for consumer protection, gave a speech discussing the Department's plans for enforcement of laws governing the marketing of medical products. Mr. Davis highlighted recent DOJ enforcement actions and previewed how the Department intends to approach the issue in the Trump administration. The speech was an important marker of how the current administration will navigate the tension between First Amendment protection for commercial speech and government enforcement in misbranding cases. The message: A renewed emphasis on what may be called "plus factors" and on the "rule of law" does not mean the DOJ will stop pursuing misbranding cases.

For those in the life sciences industry who expected the still-new administration to effect radical change in this always contentious area of enforcement, the speech offered little that was truly new. Now is by no means the time for industry to relax its compliance vigilance.

A brief refresher is in order. The use of a medical product – be it a drug or a device – in a way for which that product has not been approved or cleared is called an "off-label" use. "Label" refers here to the set of instructions that the Food and Drug Administration (FDA) has approved that guide the safe and effective use of the relevant product. The Federal Food, Drug, and Cosmetics Act (FDCA) does not prohibit the off-label use of a product per se, and medical providers are free to prescribe products outside of those instructions, subject to any applicable state law, state licensing limitations, and professional standards. The FDCA and its implementing regulations, however, do limit the extent to which manufacturers can promote products for off-label uses. For decades, the FDA and DOJ have brought enforcement actions alleging that off-label promotion of a drug or medical device violates the law.

The government's ability to bring enforcement actions based on off-label promotion has been hampered by recent landmark cases. In 2012, the Second Circuit overturned the conviction of a pharmaceutical sales representative who made statements promoting an off-label use for a prescription drug in United States v. Caronia. The case set out important limitations on the government's ability to bring enforcement actions based on a theory that off-label promotion rendered a product misbranded or otherwise caused the sale of the product to violate the FDCA. Three years later, in Amarin Pharma v. FDA, the Southern District of New York granted an injunction barring an FDA enforcement action as infringing free speech. In both cases, courts rejected government theories that truthful and non-misleading off-label promotion, in itself, could lead to an FDCA violation. Industry pointed to the cases as major victories for commercial speech.

Caronia and Amarin, among other cases, seemed to spur considerable government activity, as it struggled with how to draw the boundaries between the First Amendment and the FDCA. While the Obama administration made efforts to define that boundary, little was settled as the new administration began.

Mr. Davis's speech provides important insight into how the government now plans to procced. Three aspects of the speech merit specific attention, as they pertain to off-label promotion. First, DOJ will not back away from enforcement cases that have off-label promotion at their core – Mr. Davis signaled no radical change in how the government enforces the FDCA. But second, Mr. Davis makes clear that, as a general matter, the DOJ will focus on cases that satisfy at least one of the following specific criteria: (a) promotional activity that was false or misleading; (b) off-label use that harmed patients; and (c) conduct that misled the FDA. These criteria hark back to earlier "plus" factors – somewhat common in the Bush administration – that DOJ examined when assessing similar cases. It is important to note that Mr. Davis specifically mentioned the harm that opioid use has caused. It is also important to note, however, that, regardless of the harm that an off-label use may have caused, the government would be hard pressed to prevail in a case in which the manufacturer's promotion involved truthful and non-misleading speech. Caronia and its progeny would provide a manufacturer a robust defense to a federal action in such a circumstance. Third, Mr. Davis tied these cases to the new administration’s emphasis on the "rule of law." By that he was referring to AG Sessions' November 2017 memo ending DOJ's practice of regulation by guidance – in other words, noncompliance with guidance documents will not be seen as a violation of the law. This is particularly relevant here, as FDA has issued any number of guidance documents that discuss the ways in which it believes manufacturers can and cannot promote their products. 

Mr. Davis also used specific cases as examples of enforcement actions that the current DOJ leadership sees as consistent with the Department's future plans. His descriptions of those cases highlighted certain allegations, among them failure to adhere to Risk Evaluation and Mitigation Strategy (REMS) obligations, and failure to comply with current good manufacturing practices (cGMPs). DOJ enforcement actions in the coming months and years will tell whether there will be a sharpened focus on these types of alleged violations.

All in all, drug and medical device makers should not expect to see a major decline in DOJ enforcement actions; instead, they would do well to take stock of what Mr. Davis chose to highlight as areas of particular focus.